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Cytori Patents Method of Making Stem and Regenerative Cell-Enriched Fat Grafts

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Cytori has received US Patent No. 7,901,672 ('the 672 patent) from the United States Patent and Trademark Office for a method of enriching a patient's own fat with their own adipose derived stem and regenerative cells (ADRCs) to create a cell-enriched fat graft.

This patented method is the essence of the company's innovative procedure for treating a variety of cosmetic and reconstructive soft tissue defects and is being used in Europe and Asia as a natural filler for breast reconstruction after partial mastectomy (such as in Cytori's RESTORE 2 trial), breast augmentation, facial rejuvenation, wrinkle filling, as well as other soft tissue defects such as those secondary to radiation therapy.

The '672 patent is not limited to any particular way of obtaining the stem and regenerative cells or any particular way of enriching the fat with the cells. Accordingly, the '672 patent covers both manual and automated methods of making cell enriched fat grafts.

For example, the patented method covers cells disaggregated from the fat tissue by enzymatic digestion or mechanical force and cells concentrated by density, filtration or centrifugation. The cell-enriched fat graft may be prepared manually or in a device that operates in a closed system such as Cytori's Celution® 800/CRS System.

The '672 patent is broader than US Patent No. 7,887,795, issued on February 15th, 2011, covering a method of making a fat graft enriched with ADRCs plus an additive. Additives may include materials that enhance the delivery, efficacy, tolerability or function of the cell-enriched fat graft, e.g., antibiotics, growth factors, immunosuppressive agents and resorbable scaffolds.

The '672 patent is a significant addition to our multi-layered intellectual property strategy aimed at protecting the devices, methods and uses surrounding adipose derived stem and regenerative cells. In September 2009, Cytori received US Patent No. 7,429,488 covering the Company's Celution® 800/CRS based methods of cell enriched fat grafting.

In January 2010, the Company received US Patent No. 7,651,684 covering methods of making cell enriched fat grafts to treat soft tissue defects, promote neovascularization, or reduce necrosis in the breast, lips, wrinkles, undereyes, cheeks, thighs, arms, abdomen, urethral sphincter, rectal sphincter and other areas of the body using the Company's current Celution® 800/CRS system.

The '684 patent also covers methods using alternative device configurations such as desktop versions with accelerated processing times tailored to smaller volume procedures. Cytori now has 31 issued patents worldwide and over a 100 pending patent applications.